MedTrace Logo

Conditionally Increased Output (CIO) Enhanced Ultrasound System

NCT05792423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-05-23

Study results available
· View outcomes & findings →

Summary

This study aims to assess possible bioeffects that may be caused by the use of shear wave elastography (SWE) with conditionally increased acoustic output pressure (CIO). Bioeffects will be monitored by of a series of liver function tests (LFTs) with results graded according to the NCI scale for drug hepatoxicity. LFTs will be collected prior to SWE imaging using CIO, as well up to 7 days post-imaging. Secondarily, this study aims to understand the degree to which SWE imaging results have improved with the use of COI.

Conditions

Interventions

DEVICE

GE ultrasound system with increased acoustic output settings

We will perform liver stiffness measurements with standard settings and an increased acoustic output enhanced ultrasound system. Pre and post ultrasound LFTs will be collected to monitor unexpected liver tissue damage.

Sponsors & Collaborators

  • GE Healthcare

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2024-05-31
Completion
2024-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05792423 on ClinicalTrials.gov